On Monday (October 23rd), the High Court of Delhi heard the challenge to the grant of patent to Gilead Pharmasset’s for compound used for preparing Sofosbuvir – a Hepatitis C drug. The petitioner-Sankalp Rehabilitation Trust, an NGO working with injecting drug users and persons affected by HIV/AIDS was represented by Senior Advocate Anand Grover.
The patent application for Sofosbuvir, has been the subject matter of challenge worldwide by civil society organisations and patient groups alike. In India, the patent was granted by the Patent Controller on 9th May 2016 after rejecting the oppositions filed by patients’ rights groups as also generic companies.
Gilead had filed a patent application in India in December, 2005. In 2009, two parties (Delhi Network of Positive People along with IMAK, and Natco Pharma Ltd., a generic pharmaceutical company) filed oppositions at the Patent Office against grant of patent to the application for Sofosbuvir.
In what appeared to be a tactic to avoid any further objections to the application by generic pharma companies, in late 2014 Gilead entered into licence agreements with 13 Indian generic pharma companies to manufacture and sell Sofosbuvir in countries identified in the license. Natco Pharma Ltd. being one such licensee withdrew its opposition to the patent application for Sofosbuvir in India. Important to note is that these licenses exclude most high-burden countries like Brazil, pushing one to probe the real intent of such licenses.
In 2015, the Patent Office after considering oppositions against the patent application for Sofosbuvir refused the grant it a patent. Gilead filed a writ petition before the Delhi High Court against this refusal. The Delhi High Court found that Gilead was not given proper notice of the objections and remanded back the matter to the Patent Office for fresh hearing. The High Court also allowed new pre-grant oppositions to be filed against the patent application.
Given the increased challenges worldwide on its patent eligibility and the importance of Sofosbuvir for persons not only affected by Hepatitis C but also HIV/AIDS, Lawyers Collective was approached by Sankalp Rehabilitation Trust, an NGO working with injecting drug users and persons affected by HIV/AIDS, to file an opposition against the said patent application. An opposition against the application was drafted and filed subsequent to the Delhi High Court’s order for fresh hearing of the oppositions.
Subsequent to the rejection of its opposition and grant of the patent in May, 2016, Sankalp challenged the patent grant on the ground that the Controller failed to apply the settled principles of law in determining obviousness and novelty. An invention is said to be obvious when a person having ordinarily skilled in said field of technology would have developed the same invention by referring to material available to the public as on the date of filing the patent application. It is trite law that in determining obviousness the prior publications are not to be looked at in isolation but different publications may be put together to examine whether an alleged invention is obvious. Sankalp argued that the order granting the patent has looked at the prior teachings in isolation, thereby not following the established principles of determining obviousness.
Sankalp further argued that the Dy. Controller failed to take note of an order of the District Court of Northern District of California, San Jose Division, which had found that Gilead’s Sofosbuvir infringed earlier patents of Merck & Co., Inc. It was Sankalp’s case that the ruling of the District Court which clearly indicated that Gilead’s ‘invention’ was not novel and the Dy. Controller has granted a patent in error by ignoring this ruling. It was also submitted by the Petitioner that Gilead amended its claims after the hearing before the Controller had concluded. The Controller neither notified nor granted an opportunity to the Opponents to challenge the amended set of claims. Sankalp submitted that for the aforesaid reasons, the order of the Patent Controller should be quashed and the patent should be set aside.
The Respondents will now be heard on November 7.
Read related article: The Chronicle of the Hepatitis C drug – Sofosbuvir
Priyam Lizmary Cherian is a Legal Officer at Lawyers Collective